Permanent dermal filler

Frequently asked questions

Why can’t we name this product and why are we calling this treatment a “permanent  filler"?

Australian TGA (Therapeutic Goods Administration) regulations have prevented the naming of this well known treatment as it is deemed to be direct advertising of a "doctor only" medically prescribed S4 medication. It is an extremely safe treatment that has been used successfully in facial cosmetic medicine for many years, providing it is administered by a qualified doctor who has been well trained in the correct technique.

What is a “permanent filler”?

This is a long-term dermal filler where the volume of the implant is given by water, not from a solid product. This permanent filler is made of 2.5% "filler" and 97.5% water. The cross-linked "filler" forms a real gel, which does not contain any solid microparticles. This makes it soft and uniform. It is injected under the skin where it can't be seen or felt and remains in place permanently. Being mostly water, the body accepts the gel readily and only forms a thin membrane around the implant which helps to keep it in place; as the gel is very elastic it moves with all facial expressions.

This filler has now been used in cosmetic and plastic surgery for more than ten years. Studies demonstrate that this is a transparent, injectable gel for correction of soft tissue deficiencies and tissue augmentation.

This permanent filler is produced by Ferrosan A/S, a Danish pharmaceutical company founded in 1920. Ferrosan A/S [via their subsidiary Contura] has obtained full rights to manufacture, sell and market the gel internationally.

What are the benefits?

This unique gel is:

  1. Permanent
  2. Non absorbable
  3. Biocompatible
  4. Non toxic
  5. Non allergenic
  6. Does not migrate from the injection site.

This permanent filler has been specially designed for correction of facial contour deformities due to ageing, acne, trauma, surgery and infection or due to congenital deformities, and can be used for:

  1. Cheekbones
  2. Smile lines
  3. Lip augmentation
  4. Frown lines
  5. Depressed corners of the mouth and marionette lines
  6. Chin
  7. Tissue reconstruction following lipodystrophy or surgery
  8. Other soft tissue deficiencies of the face such as scars etc

When is this not appropriate for use?

This permanent filler is not indicated for treatment of fine wrinkles.

This permanent filler should not be injected at a site already treated with another permanent filling product. It can be injected elsewhere in that patient.

If other non permanent filling products have been used, injection of this permanent dermal filler should wait until the first product has disappeared (approx 6 months).

Treatment should not be administered if there is infection of any type on the skin.

What can I expect from this procedure?

This permanent filler is unique due to its stability and long lasting cosmetic results. After the injection a thin layer of the body's own connective tissue surrounds the gel, enabling this permanent filler to become a stable part in the connective tissue.

This permanent filler can be removed shortly after the injection if necessary. If the gel has to be removed at a later stage, a minor surgical procedure might be necessary, the success rate of which is variable.

This filler is considered to be non-toxic because of the inability to pass biological membranes due to the large molecular size. Additionally, it is extremely resistant to biodegration. Polyacrylamides are used widely in biomedical research and in the biomedical industry. This permanent filler is a cross linked substance, which makes it stable and practically impossible for human body enzymes or bacterium to metabolise the product. Due to this and a high viscosity the gel remains in place at the site of injection and behaves as a natural part of the skin.

How does this product perform?

This permanent filler is homogeneous and does not contain any hard particles (microballs or microcrystals). The effect is clearly linked to the volume injected, so the deeper the defect the more product will be required. This permanent filler does not migrate; it is stable and inactive at the site of injection. It remains soft after injection and the implant is not distinguishable from the surrounding skin by palpation. The effect of the injection of this filler is permanent. Since the ageing of the skin continues, it may be necessary to carry out follow-up injections after a certain period of time, depending on a number of factors (skin structure, age, etc.)

Is it safe?

This permanent filler has been used for aesthetic correction for more than ten years in 30,000 patients. Retrospective studies have not shown any long-term side effects, clinically and histologically. Numerous toxicological studies have been carried out on animals. They have shown that implants of this gel are tolerated for long periods of time without biodegradation. Preclinical studies have not shown any cytotoxic effects, any systemic or pyrogenic effect, or any effect on the blood or on enzyme activity. This substance has been used for many years in the United States and Europe for treatment of drinking water.

What are the possible side effects?

Injection of this permanent filler causes only mild reaction in the surrounding tissue which is minimal compared with reactions to other foreign bodies and most temporary fillers. This indicates that the gel is well tolerated by the human body. There is no calcification, no Cancer causing effect, no inflammation and no local allergic reaction. The gel is not found in the lymph nodes. This permanent filler does not cause any allergic reaction or any other immunological effect either in animals or in humans. This permanent filler does not migrate. Adverse effects are seen in relation to 1-2% of injections mostly infection which is easily treated. Temporary reactions typically connected with injection may appear, for example reddening, pain, oedema, itching at the site of injection. Within 1 -2 weeks after treatment 1 out of 1500 patients have a risk of developing transient swelling and tenderness near injection sites. If not caused by infection these reactions are self limiting and will resolve in a couple of weeks.

What is the post treatment regime?

The patient should not expose the treated zone to intense heat (sun bed, sunbathing) or extreme cold in the first days following treatment. The purpose of this is to avoid inflammation of the zone where the injection has been made. The area should be kept clean and touching of the area avoided for the first few days after treatment. Any discomfort should respond to paracetamol. Should any problem arise it is important to contact the treating physician, as most problems are easy to resolve if treated quickly.

It is a safe product. Interim reports from a clinical trial started in January 2001 involving 243 patients in Europe, report no serious adverse events.

What is this procedure recommended for?

  1. Deep facial lines (such as the naso labial folds)
  2. Enhancing lips
  3. Replacing facial volume lost from age
  4. More prominent cheek bones
  5. Stronger jaw line
  6. Facial deformities
  7. Depressed scars

When was this procedure developed?

This permanent filler obtained CE marking in March 2001. This marking, which is granted by an independent notified body, certifies that the production of this permanent filler takes place in compliance with European norms and that the product has proved to be harmless and efficient in human beings.

What does the  ce0543 mark mean?

This is the number from the notifying body in Denmark (DGM) which is audited by MDA in London. A notified body is an institution that issues CE certificates, i.e. grants CE marking to products that have been approved for sale in the European Community. The CE mark indicates that this permanent filler meets the requirements formulated in EU Directive 93/42

How is the filler made?
This permanent filler is made in Copenhagen, Denmark, at the pharmaceutical company Ferrosan NS. The production takes place in sterile surroundings. In addition the gel is sterilised by means of autoclave sterilisation in the syringe.

Why is this filler so long lasting?

Because the substance forms long chains that cannot be split by the human body. No enzyme or bacterium is able to metabolise the polyacrylamide. This is the reason why the gel remains in place at the site of injection and remains as a part of that tissue.

How can we be sure about long-term safety?

We can trust this product’s safety because it has been used for aesthetic correction for more than ten years in 30,000 patients. Retrospective studies have not shown any long-term side effects, clinically and histologically. Numerous toxicological studies have been carried out on animals. They have shown that implants of this substance are tolerated for long periods of time without biodegradation.

Preclinical studies have not shown any cytotoxic effects, any systemic or pyrogenic effect, and any effect on the blood or on enzyme activity. This substance has been used for many years in the United States and Europe for treatment of drinking water. Injection of this permanent filler causes only mild reaction in the surrounding tissue which is minimal com- pared with reactions to other foreign bodies. This indicates that the gel is well tolerated by the human body. There is no calcification, no carcinogenic effect, no inflammation and no local allergic reaction. The gel is not found in the lymph nodes. This permanent filler does not cause any allergic reaction or any other immunological effect either in animals or in humans. This permanent filler does not migrate. In fact, its high molecular weight makes migration impossible.

Does the material grow in size after injection?

The result obtained immediately after the injection is the visible, definitive result. This permanent filler l requires neither under correction nor overcorrection.

What will happen if this permanent filler is not injected at the subcutaneous level?

The gel must be injected subcutaneously. It should not be injected into the superficial dermis or the intermediate dermis, since the consequences of such injections are not known. If an injection is too superficial, the aesthetic result may not be as desired, since the surface will not be smooth.
If necessary, the gel can be withdrawn with a 19G needle inserted into the gel. The gel can be diluted by means of a solution of sodium chloride or anaesthesia, which will facilitate the removal of the gel.

Can this permanent filler be injected to eliminate fine wrinkles?

Permanent dermal filler is not indicated for treatment of fine wrinkles. There are other, better suited fillers for this purpose.

What are the possible side effects?

Temporary reactions typically connected with injection may appear, for example reddening, pain, oedema, itching at the site of injection. Adverse effects are seen in relation to 1-2% of injections. They are mainly due to the quality of the injection and of hygienic standard and sterility.

Can permanent fillers be used in association with other types of injectable implants?

This permanent filler should not be used in a site where a non-soluble filling product has previously been injected. In sites previously treated with a soluble filling product, an injection of this permanent filler should not be made until the soluble product has disappeared completely.

It is a contraindication for the use of this permanent filler if the site in question has already been treated with injections of a permanent filling product. If other filling products have been used, injection of this permanent filler should wait until the first product has disappeared.

Can this permanent filler be used between the eyebrows?
Treatment of the area between the eyebrows is one of the indications for this permanent filler.

Can you treat a person suffering from an autoimmune disorder?
Yes. Autoimmune disorders are not a contraindication for injection of this permanent filler.

What about immune deficiency?
Yes. Immune deficiency is not a contraindication for injection of this permanent filler.

What about someone with facial herpes?
The very injection process constitutes a risk, since the injection of the needle into the skin may contribute to provoking an outbreak of facial herpes. Prevention of an outbreak of herpes by means of an oral antivirus drug is recommended. Never use this permanent filler when having an outbreak of herpes labialis.

Prescription of a prophylactic treatment with an oral antivirus drug is recommended in the case of patients suffering from recurrent facial herpes.

Pregnant or breastfeeding women?

Since there is no clinical evidence of this permanent filler in pregnant and breastfeeding women it is advisable not to use it for pregnant or breastfeeding women.

Can this procedure cause hyperpigmentation?

No hyperpigmentation reaction has been registered following injection of this permanent filler.

How does this procedure react with the area is exposed to sunlight?

The patient should not expose the treated zone to intense heat (sun bed, sunbathing) or extreme cold in the first days following treatment. The purpose of this is to avoid inflammation of the zone where the injection has been made.

Are there any interactions with systemic treatments?

There is no interaction between systemic treatment and this permanent filler, since it is stable, inactive and bio- compatible and does not migrate.

What do I need to know about this product and ageing?

This permanent filler is a gel, which is a 3 dimensional-body composed of a skeleton of polymer in water environment. This permanent filler contains about 2-3% of a cross-linked polymer network and with the remaining part of 97-98% being water. Monomer chains are held together by covalent bindings, whereas water is attached to the polymer network with weaker bounds. The molecule is not dissolved in water, but "swollen" like a sponge. The gel is in dynamic equilibrium with the surrounding tissue, but still the polymer retains its ability to hold water and remains elastic over an extended time.

The ageing process of the skin represents a combination of gravity effect and skin atrophy itself. Skin becomes thinner and loses its elasticity. Subcutaneous tissue flattens. Therefore attempts have been made to restore the volume and increase tissue elasticity. A large amount of different substances are currently used as volume fillers. This permanent filler is used as a fat substitute. Once injected, this permanent filler becomes a stable part in the soft tissue. When palpating, this permanent filler feels soft and elastic like normal tissue.

This gel has been used for aesthetic and reconstructive surgery for more than 10 years. Thousands of patients have been injected with the gel for various indications. Retrospective studies on patients having gel injected for 1-9 years showed no concerns with respect to product safety as well as aesthetic result. Histology samples taken from patients 1-9 years after gel injection reveal a high biocompatibility of the product. This gel induces only very mild foreign body reaction with no strong fibrous reaction or calcifications common for other implants. There is no difference between tissue reactions over many years.

With ageing, this permanent filler will follow the tissue movements, which could be more visible in lower parts of the face like mentolabial folds. This will result in an unsatisfactory aesthetic result and therefore additional injections may be necessary. It has to be remembered that this permanent filler is not a substitute for a face-lift, since it only cures effects of gravity. Nevertheless, this permanent filler can be used as a supplement to achieve "volumetric face lift".

This permanent filler is elastic filler consisting mostly of water. In contrast to a number of various implants, this permanent filler does not interfere with a natural growth/movement of the tissue. Thus, polymer gel implants are successfully used in children since the gel can follow the tissue growth and therefore does not cause asymmetry of the face.